Me: 12% Patent Pending

We did not always understand the role of germs in causing disease. Indeed, the germ theory of disease was controversial until Louis Pasteur reported the results of decisive experiments that demonstrated that micro-organisms are responsible for the spoiling of milk, wine, and beer. The eponymous method of pasteurization that he developed to kill the micro-organisms is still used today. Extending the idea of infection by micro-organisms led him to solve what were at the time mysteries of how rabies, anthrax, and silkworm diseases were caused. It led him to diverse discoveries important both in the development of vaccines and in understanding the scientific basis for fermentation to make beer and wine.

It was in this last area that I am particularly interested in today, because it was in that area that Pasteur was granted one of the very earliest patents for an organism. Some speculate that the claim in his U.S. Pat. No. 141,072 (which can be found here) slipped in quietly, its importance not fully understood by the Patent Examiner. But whether the Examiner was conscious of it or not, Pasteur was granted a patent on July 22, 1873 in which he claimed “Yeast, free from organic germs of disease, as an article of manufacture.”

Almost exactly 100 years after Pasteur filed his patent application, Ananda Mohan Chakrabarty would become famous in the would of patent law when he genetically engineered a bacterium derived from the Pseudomonas genus so that it effectively broke down the components of crude oil. The idea was that it would be useful in dealing with oil spills. But the issue that was perhaps finessed by Pasteur then came squarely before the Supreme Court of the United States: can a lifeform be patented? It was a close call. A bare majority of the Court, guided by Congress’s assertion when it passed the modern Patent Act that it intended to “include anything under the sun that is made by man,” concluded that genetically engineered organisms could be patented. A copy of the 1980 decision can be read here.

Things have only continued to get more interesting. Indeed, in the world of patent law, the most famous animal is undoubtedly the Harvard oncomouse, the first animal in the world created by genetic engineering. In 1984, Philip Leder and Timothy Stewart of Harvard University introduced a specific gene — called an “activated oncogene” — into mice, deliberately increasing the mice’s susceptibility to cancer, specifically in a way that generally mimics the course of the disease in humans. The idea was that the high susceptibility to cancer would make the oncomouse an ideal research tool so that any variety of experiments involving cancer would be simplified, whether for treatment of tumors or simply to understand the mechanism by which tumors are created.

The oncomouse was patented in the United States on April 12, 1988 and in Europe on May 13, 1992. Similar patents have also issued in Japan and New Zealand. While the general acceptance by most countries that genetically modified organisms are patentable has almost certainly contributed to promoting efforts in the biotechnology research fields, many people still have considerable discomfort with it. Consider, for instance, that the Supreme Court of Canada rejected the patenting of the oncomouse, even over dissents that wanted to follow the American example more closely. A copy of the Canadian decision can be found here.

Even more alarming to many is that since Chakrabarty the U.S. Patent and Trademark Office has been issuing patents that are directed not only to engineered organisms and not only to synthetic DNA but also to unaltered genomic DNA — human genes. Indeed, there are currently about 40,000 patents that cover sections of the human genome: of the roughly 25,000 or so genes that define “me,” about 3,000 of them have some kind of intellectual property claim over them. Somewhat surprisingly, no U.S. court has actually ruled on whether these kinds of patent claims are legitimate — until now.

In Association for Molecular Pathology v. U.S. Patent and Trademark Office, a lower court ruled that such claims are not patentable. The crux of the reasoning is quite simply that even if we accept that anything under the sun made by man might be patentable — those things that are made by nature, like genomic DNA, are not patentable. A copy of the decision can be read here.

The case is currently under appeal. What surprised many is not that the case was appealed. After all, the conclusion is a critically important one that will not only affect the validity of tens of thousands of patents, but will also have numerous ripple effects: funding for research programs investigating genetic disease will be affected, the viability of companies employing thousands of people to research genetic disease will be impacted, and there will be some effect on how quickly results of that research develop into effective treatments for people. The underlying question is the age-old one: does granting patents in this area promote or inhibit technological progress? What did surprise many is that the U.S. Justice Department filed an amicus brief in the case last month arguing that such claims are not patentable. A copy of the government’s brief can be found here.

It is astonishing to think that something like 12% of me has been patented and my instinctive reaction is to be offended. It seems so intrusive. They’re my cells — hands off. The issue raises deep and profound questions that need to be addressed. But at the same time, patents are temporary, lasting only twenty years, and it is very possible that issuing patents on genes can spur medical marvels. Enduring a relatively brief period with what is mostly an abstract offense might not be so terrible.

Perhaps in time, our descendants will consider the astonishing freedom they have from genetic disease and will consider us fondly. “It was they who literally gave up ownership of themselves for our health.”

The author, Patrick M. Boucher, is a patent attorney living near Denver, Colorado and working at Marsh Fischmann & Breyfogle. He holds a Ph.D. in physics as well as a J.D. He is an active member of the American Physical Society, and is admitted to practice law in the states of Colorado and New York, as well as to practice before the U.S. Patent and Trademark Office. He is also a member of the Authors Guild and of the Colorado Authors League.